Vaccines containing antigens from more than one pathogenic organism within a single dose are known as “multivalent” or “combination” vaccines. Various combination vaccines have been approved for human use in the EU and the USA, including trivalent vaccines for protecting against diphtheria, tetanus and pertussis (“DTP” vaccines) and trivalent vaccines for protecting against measles, mumps and rubella (“MMR” vaccines). Combination vaccines offer patients the advantage of receiving a reduced number of injections, which can lead to the clinical advantage of increased compliance (e.g. see chapter 29 of reference 1).
Streptococcus agalactiae (Group B streptococcus, GBS) is a haemolytic, encapsulated Gram positive microorganism that colonizes the anogenital tract of 25-30% healthy women. GBS causes neonatal infections in infants born to mothers carrying the bacteria and is a major cause of neonatal sepsis and meningitis. The pathogen is also increasingly recognized as an important cause of disease in adults, particularly those with underlying disease, and in the elderly.
Conjugate vaccines against Streptococcus agalactiae have been described in documents such as references 2 to 10. Conjugate vaccines for each of GBS serotypes Ia, Ib, II, III, and V have been shown to be safe and immunogenic in humans [11]. Reference 12 also discloses various GBS conjugate-containing vaccines.
It is an object of the invention to provide further and improved combination vaccines for protecting against Streptococcus agalactiae and one or more of Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and Poliovirus.